FDA.reportPublic FDA data

Chord-X Premeasured Loops and Suture System

Primary DI
00813570020022
Brand
Chord-X Premeasured Loops and Suture System
Company
ON-X LIFE TECHNOLOGIES, INC.
Model
CXL-20-2212-16
Catalog number
CXL-20-2212-16
Device description
Artificial chordal replacement prosthesis
Published
2015-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or ReplacementCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141060000CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENTOn-X Life Technologies, Inc.2014-06-06PAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813570020428PackageGS15In Commercial Distribution
00813570020022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813570020428008135700204288135700204280813570020428
00813570020022008135700200228135700200220813570020022

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.3195Millimeter

Contacts#

Phone, Email table
PhoneEmail
512-339-8000onx@onxlti.com

Regulatory Flags#

DUNS number
844782318
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851788001495Chord-X Chordal SizerCXCSCXCS2023-10-12
00851788001020On-X Heart Valve InstrumentsONXI2-19RONXI2-19R2023-08-09
00851788001037On-X Heart Valve InstrumentsONXI2-21RONXI2-21R2023-08-09
00851788001044On-X Heart Valve InstrumentsONXI2-23RONXI2-23R2023-08-09
00851788001051On-X Heart Valve InstrumentsONXI2-25RONXI2-25R2023-08-09
00851788001068On-X Heart Valve InstrumentsONXI3-19SONXI3-19S2023-08-09
00851788001082On-X Heart Valve InstrumentsONXI2-19SONXI2-19S2023-08-09
00851788001099On-X Heart Valve InstrumentsONXI2-21SONXI2-21S2023-08-09
00851788001105On-X Heart Valve InstrumentsONXI2-23SONXI2-23S2023-08-09
00851788001112On-X Heart Valve InstrumentsONXI2-25SONXI2-25S2023-08-09
00851788001129On-X Heart Valve InstrumentsONXI2-27-33SONXI2-27-33S2023-08-09
00851788001136On-X Heart Valve InstrumentsONXI2-23-25SONXI2-23-25S2023-08-09
00851788001143On-X Heart Valve InstrumentsONXI2-27-29SONXI2-27-29S2023-08-09
00851788001150On-X Heart Valve InstrumentsONXI2-HONXI2-H2023-08-09
00851788001167On-X Heart Valve InstrumentsONXI2-LPONXI2-LP2023-08-09
00851788001174On-X Heart Valve InstrumentsONXI2-CTONXI2-CT2023-08-09
00851788001181On-X Heart Valve InstrumentsONXI3-21SONXI3-21S2023-08-09
00851788001198On-X Heart Valve InstrumentsONXI3-23SONXI3-23S2023-08-09
00851788001556On-X Heart Valve InstrumentsONXI3-27-29SONXI3-27-29S2023-08-09
00851788001563On-X Heart Valve InstrumentsONXI3-23-25SONXI3-23-25S2023-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813570020008Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020039Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020046Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020053Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020060Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020077Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020084Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020091Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020107Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020114Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020121Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020138Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020145Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020152Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020169Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020176Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020183Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020190Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020206Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020213Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020220Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020237Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020244Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020251Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020268Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020275Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020282Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020299Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020305Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020312Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01